Senior Director, RA Global Regulatory Strategy
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Senior Director Regulatory Affairs Global Regulatory Lead Global Regulatory Strategy (GRS), is responsible for developing and implementing global regulatory strategies, with specific responsibility to lead the US and Canada strategies. Leads the Global Regulatory Product Team (GRPT) Accountable for ensuring that corporate goals are met and the success of the team is realized. Manages the content of global regulatory dossiers and is a key leader and a driver strategy. Serves as the primary regulatory interface with ADT, ALB, CST, GCT, GBT, PST, and anticipates, prioritizes and mitigates regulatory risks while ensuring compliance with all global regulatory requirements. Ensures successful decision-making for submissions and approvals and is also responsible for managing direct reports. Only maximum of 1000 characters allowed. You must specify a value for this required field
- Leads and manages a team of global regulatory professionals for development and marketed products. Accountable for ensuring that corporate goals are met. Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned products.
- Leads preparation of global regulatory product strategies for assigned products. Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.; is specifically responsible for the US and Canada strategies, as well as IND and marketing dossier submission and maintenance activities.
- Provides executive management with meaningful regulatory strategies and risk assessment.
- Acts independently under the direction of a GPS TA Head. May participate in or lead initiatives. Responsible for the performance management for other RA GRPT team members and direct reports. Responsible for recruiting and onboarding or new team members. Influences the development of regulations and guidance. Advises management of the effect of current, newly finalized or proposed laws, regulations, guidelines and standards, advisory committee recommendations on assigned products.
- Advises internal personnel on regulatory strategies. Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department and, if applicable, ensures direct reports follow requirements.
- Informs regulatory management of important timely issues and the impact on the global program. Provides executive management with meaningful regulatory measurements and regulatory opinion.
- Develops, communicates and builds consensus for operating goals that are in alignment with the division. Under supervision of a Director or TA Head, creates and communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management.
- Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
- Follows budget allocations and keeps supervisor informed on project resourcing.
- Required Education: Bachelor's degree (pharmacy, biology, chemistry, pharmacology) related life sciences
- Preferred Education: Relevant graduate degree preferred. Certifications a plus
- 7+ year’s regulatory experience. 10+ years in pharmaceutical, R&D or industry related experience required. Proven 3-5 years in a leadership role with strong management skills. Experience working in a complex and matrix environment, and with multiple stakeholders
- Strong communication and proactive negotiation skills. Experience contributing to enterprise management of a portfolio of products
- 10 years’ experience in pharmaceutical regulatory activities preferred; preferably with experience as lead regulatory product strategist in at least one major region such as US, EU, JAPAC
- Experience interfacing with government regulatory agencies. Experience developing and implementing successful global regulatory strategies. Strong clinical foundation preferred with business acumen
- Experience working with multiple functions (AD/PROMO, Labeling, CMC devices, etc.) and cross-functional teams
- Note: Higher education may compensate for years of experience
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 20 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.